Future of the EU biotechnology and biomanufacturing sector: leveraging research, boosting innovation and enhancing competitiveness

Wording as published by the EP, in English.

1. Amendment 1Rejected

   Citation 2 a (new)

   Tabled by Viktória Ferenc, Kinga Gál, Enikő Győri +71 · Members

   Added: – having regard to the UN Universal Declaration on the Human Genome and Human Rights;

2. Amendment 2Rejected

   Recital S a (new)

   Tabled by Viktória Ferenc, Kinga Gál, Enikő Győri +71 · Members

   Added: Sa. whereas such a framework and the ethical foundation of the EU should be based on core values such as the inviolability of human dignity, the integrity of the person, the primacy of the human being over the sole interests of science or industry, the prohibition of reproductive cloning and eugenic practices, the requirement of free and informed consent for any medical intervention, the prohibition of financial profit from the human body and its parts, the non-patentability of living human matter, and the rejection of discrimination based on genetic characteristics; whereas this must include, among other things, strict compliance with rules on genetically modified organisms (GMOs), the prohibition of certain biotechnological practices deemed incompatible with human dignity and characteristics of human species and sexes, safeguards concerning the prohibition of enhancement of human embryos and germ cells, regulations on the use of stem cells and synthetic gametes, prior authorisation procedures for clinical and medical applications, transparency obligations and requirements for the protection of genetic data; whereas the Member States must retain the right to adopt more restrictive measures in the field of bioethics, without such measures being regarded as obstacles to the functioning of the internal market or to the development of the EU’s industrial strategy;

3. Amendment 3Rejected

   Paragraph 1

   Tabled by Viktória Ferenc, Kinga Gál, Enikő Győri +71 · Members

   … biotechnology and biomanufacturing sector and the need for the EU to remain Removed: world-leading in this field; Added: world leading in these fields; underlines the commitment to the principles of better regulation and lawmaking, simplification and administrative burden reduction; underlines Removed: that the simplification of EU legislation must not endanger any of Added: the importance of always protecting the fundamental rights of citizens, workers and Removed: businesses or risk regulatory uncertainty; believes that any simplification proposal should not be rushed and proposed without proper consideration, consultation and impact assessments; Added: businesses; therefore asks the Commission, if Removed: it proposes a new EU-wide regulation in the form of an EU Removed: biotech act, Added: Biotech Act is proposed, to address concrete gaps and shortcomings in current legislation and implementation, and to present legislation that can be revised, simplified, streamlined, repealed Removed: and which reduces bureaucratic burdens, Added: or by which bureaucratic burden can be reduced, focusing on the specificities of the industry and maintaining relevant safety and security Removed: standards; Added: standards of quality and safety, while also being consistent with bioethics and human dignity; asks that an EU Removed: biotech act Added: Biotech Act adopt a comprehensive cross-sectoral scope and that it be accompanied by an … scale-ups, as well as the interaction with other relevant legislative and non-legislative Removed: initiatives, Added: initiatives including proposals currently undergoing the co-legislative procedure; Added: calls, in any case, on the Commission to review EU legislation that may affect the sector in order to identify potential barriers to the industry and to carry out the necessary amendments to or repeals of EU legislation, including those stemming from the European Green Deal;

4. Amendment 4Rejected

   Paragraph 8

   Tabled by Viktória Ferenc, Kinga Gál, Enikő Győri +71 · Members

   … self-sufficiency in key feedstocks, raw materials and components; recalls the precautionary principle Removed: laid down in Article 191 TFEU; Removed: urges the Commission Added: stresses, however, that an approach disproportionately focused on environmental impact, without taking into account economic and social factors, has already caused harm in other industrial sectors; calls on the Commission to carry out a well-designed impact assessment to ensure that the new biotechnology strategy is a driver of growth and innovation, rather than a generator of unnecessary obstacles; urges the Commission, furthermore, to share with Parliament the preliminary findings of its study on regulatory Removed: burden, in this regard, Added: burden and the potential need to review legislation related to biotechnology and biomanufacturing; … access, while maintaining a risk- and science-based approach and avoiding regulatory uncertainty; Added: stresses, nevertheless, that such regulatory simplification must under no circumstances come at the expense of the Member States’ bioethics rules;

5. Amendment 5Rejected

   Paragraph 26 a (new)

   Tabled by Viktória Ferenc, Kinga Gál, Enikő Győri +71 · Members

   Added: 26a. Calls on the Commission to ensure that the proposal on biotechnology is in line with principles such as the respect for life and the protection of human dignity, and to guarantee that all efforts in the fields of innovation and regulatory simplification remain compatible with the highest standards of human dignity and public health; stresses that any restrictive measure adopted by a Member State on bioethical grounds – whether concerning the use of genetic engineering, synthetic biology or the manipulation of sensitive biological material – must not be regarded as an obstacle to the integration of the internal market or to industrial development, but rather as the legitimate expression of a national constitutional identity, public order and sovereign ethical choices, in accordance with Union law and the principle of subsidiarity; supports a regulatory approach based on the precautionary principle and a commitment to high ethical standards, in contrast with the product-based, innovation-driven frameworks; insists that, due to its sensitive nature, the biotechnology sector requires a principle of ethical risk assessment to ensure a balanced approach between innovation and competitiveness, freedom of research, respect for human dignity and the protection of populations;